Implantable miniature telescope receives FDA approval for end-stage AMD

SARATOGA, Calif. — The U.S. Food and Drug Administration has approved VisionCare Ophthalmic Technologies' implantable miniature telescope for end-stage age-related macular degeneration, the company announced.

The approval follows the announcement of results from a pivotal clinical trial demonstrating that patients implanted with the miniature telescope achieved clinically meaningful gains in visual acuity and quality of life, according to a press release.

Designed by Isaac Lipshitz, MD, the implantable miniature telescope is indicated for monocular implantation in patients age 75 years or older with bilateral central scotomas secondary to end-stage AMD and best corrected distance visual acuity between 20/160 and 20/800. The device can improve central vision by rendering enlarged images over a broad area of the implanted retina, allowing for the non-implanted eye to provide peripheral vision.

The telescope implant is part of VisionCare's CentraSight patient care program, which provides patient management as well as reimbursement resources for both patients and physicians.

VisionCare plans to submit an application to the Centers for Medicare and Medicaid Services for a new code to establish Medicare beneficiary access for the implantation procedure, the release said. In addition, the company will conduct a post-approval study to monitor patient outcomes under commercial conditions, as well as a second study to follow clinical trial patients for an additional 2 years.

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